BeeSafe’s consulting services cover two main areas:
- Consulting during the registration process of veterinary medicinal products (VMP) for bees (like varroa treatments).
- Risk assessment of agrochemicals on bees.
These two areas involve different authorities in the EU: EMA deals with the registration of VMPs, including bees. At the moment, there’s only a guideline for the development of varroa treatments. However, the general guidelines for Good Clinical Practice (GCP) apply also for honey bees. EFSA, on the other hand, deals with feed supplements for managed animals like honey bees.
For agrochemicals, this is mainly EFSA, who just reviewed its bee guidance on the risk assessment of pesticides. In addition, there’s a new guidance for the risk assessment of biocides on bees published by ECHA. These documents are still waiting for the final steps of approval by the EU Commission to be implemented. However, these guidances are part of wider aim to halt pollinator decline by 2030 in the EU. Therefore, it’s highly probable that these rules will apply in the future.
Consulting in the registration of VMPs for bees
To help you navigate the registration of VMPs for bees, BeeSafe’s consulting services in this area follow a three-step process:
In the first step, we have a short (30 minutes) videocall to know each other and line out the project. This helps to offer you the right services and to define if your needs and my expertise match. If this is the case, you decide if you want to work with BeeSafe.
Two steps to a successful registration
The second step is a data gap analysis. Here, I review already existing data and studies to define if they’re already sufficient to put the dossier together or if there’s still a need for further studies. This step also defines if compliance standards were met in the existing studies or if studies need to repeated to meet these requirements. At the end of this step, you’ll get a detailed roadmap to the marketing authorisation in the EU. Or the “go” for putting together the dossier and the other activities related to the marketing authorisation. By this, you know clearly what steps are in front of you and you can plan all the necessary tasks.
This step saves time and money ensuring that the data package for the dossier is complete – which increases the chance of a successful marketing authorisation. I don’t recommend skipping this step except: you need help in any post-authorisation activities (like a renewal of an already registered product or pharmacovigilance reports).
Finally, the third step includes all services related to the marketing authorisation process, like dossier writing (Part IV), Expert Reports, etc. During the marketing authorisation process, I can also assist you in answering any questions that come up by the authorities.
After a successful registration, BeeSafe’s consulting services also include post-authorisation procedures (Expert Reports for the renewal, pharmacovigilance reports, etc.).
As you see, this step is the most diverse in the process. This is why we’ll be communicating throughout the whole process to make sure no details are left out that are needed.
Terms and conditions
Steps 2 and 3 will get a separate quote, lining out the project according to our initial conversation. Each quote will carefully outline the project and define the work to be done. Any additional requests, necessary travel, or field work will get a separate quote. By this, you have the full control of the costs and decide which modules you want to do.
The way to registration is a “done with you”: All the necessary information must be provided by the sponsor.
This includes:
- Data from studies performed during the development. For registration, these data have to be given in a study report following the general guidelines for veterinary studies. This includes following Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).
- In case of a bibliographic dossier or for supplementary information, the data must be published in peer reviewed journals.
- Any other information related to the clinical and preclinical properties of the product, grey literature, common use, etc.
BeeSafe will begin working on the project only AFTER all information is provided and will take at least six weeks to finish the project. If the work has to be finished earlier or important information is not provided beforehand, an urgency fee will be charged. The hight of this fee depends on the volume of the additional data and time constraints given by the sponsor but will be at least 800 € for less than four weeks before deadline and at least 1200 € for less than two weeks before deadline.
BeeSafe will always carefully evaluate any given information to lead your product to a successful registration. However, BeeSafe does not take the responsibility for any differing conclusions from the authorities.
BeeSafe’s consulting services for risk assessment
The risk assessment of agrochemicals on bees has changed a lot over the past years in the EU. On the one hand, there’s the revision of EFSA’s bee guidance, that ensures a more realistic risk assessment for pollinators. On the other hand, there’s a new guidance for biocides with insecticidal action, which expands the concept of risk assessment on bees.
BeeSafe is specialized on experimental work in the field, so I can help you to define and plan the correct studies for your product and its use cases. In addition, I can do Expert Reports/Opinions answering questions and requirements coming up during the assessment of the dossier. Some examples:
- Lab studies show very low toxicity for adult bees, but larvae seem to be more susceptible, with somewhat inconclusive results. BeeSafe will give you advice if it makes more sense to repeat the lab study, perform a feeding study, or if nothing of this is necessary due to an improbable exposure.
- Your product is applied during the flowering stage and the question comes up if a residue study (honey and wax) is necessary. BeeSafe will evaluate which criteria of when to expect residues are met also in the light of practical beekeeping. This gives you a realistic approach to potential residues and how to perform meaningful studies (crop, timing, etc.)
- You want to register your product in additional Member States than those you already have the Marketing Authorisation. BeeSafe helps you to bridge already existing data and to plan studies to close data gaps, if necessary.
To find out if your needs and my expertise match, in a first step, we will define the project ahead. BeeSafe will outline the milestones of the project, so that you can decide on which modules you want to address, the timing, and the order of the work. By that, you set the priorities and keep the overview during the process.
The second step is the performance of the work, which will differ depending on your requirements.
Terms and conditions
In this type of project, BeeSafe usually does modular quotes which can be booked individually or as a package. The quote will clearly define the scope of the work. Any additional requests, necessary travel, or field work will be quoted separately.
BeeSafe will carefully evaluate any given projects based on the available information. If the Sponsor does not provide necessary information, BeeSafe does not take any responsibility for differing conclusions resulting from this additional information.
Science Communication
As a special consulting service for bee research projects and non-profit organisations, I also offer science communication services. In addition, I also offer talks, trainings, and courses on bee health.